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Looking for 57-88-5 / Cholesterol API manufacturers, exporters & distributors?

Cholesterol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cholesterol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cholesterol manufacturer or Cholesterol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cholesterol manufacturer or Cholesterol supplier.

PharmaCompass also assists you with knowing the Cholesterol API Price utilized in the formulation of products. Cholesterol API Price is not always fixed or binding as the Cholesterol Price is obtained through a variety of data sources. The Cholesterol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cholesterol

Synonyms

57-88-5, Cholesterin, Cholesteryl alcohol, Cholest-5-en-3beta-ol, Dythol, Cholestrin

Cas Number

57-88-5

Unique Ingredient Identifier (UNII)

97C5T2UQ7J

About Cholesterol

The principal sterol of all higher animals, distributed in body tissues, especially the brain and spinal cord, and in animal fats and oils.

Cholesterol Manufacturers

A Cholesterol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cholesterol, including repackagers and relabelers. The FDA regulates Cholesterol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cholesterol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Cholesterol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cholesterol Suppliers

A Cholesterol supplier is an individual or a company that provides Cholesterol active pharmaceutical ingredient (API) or Cholesterol finished formulations upon request. The Cholesterol suppliers may include Cholesterol API manufacturers, exporters, distributors and traders.

click here to find a list of Cholesterol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cholesterol USDMF

A Cholesterol DMF (Drug Master File) is a document detailing the whole manufacturing process of Cholesterol active pharmaceutical ingredient (API) in detail. Different forms of Cholesterol DMFs exist exist since differing nations have different regulations, such as Cholesterol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cholesterol DMF submitted to regulatory agencies in the US is known as a USDMF. Cholesterol USDMF includes data on Cholesterol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cholesterol USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cholesterol suppliers with USDMF on PharmaCompass.

Cholesterol JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Cholesterol Drug Master File in Japan (Cholesterol JDMF) empowers Cholesterol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Cholesterol JDMF during the approval evaluation for pharmaceutical products. At the time of Cholesterol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Cholesterol suppliers with JDMF on PharmaCompass.

Cholesterol CEP

A Cholesterol CEP of the European Pharmacopoeia monograph is often referred to as a Cholesterol Certificate of Suitability (COS). The purpose of a Cholesterol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cholesterol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cholesterol to their clients by showing that a Cholesterol CEP has been issued for it. The manufacturer submits a Cholesterol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cholesterol CEP holder for the record. Additionally, the data presented in the Cholesterol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cholesterol DMF.

A Cholesterol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cholesterol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Cholesterol suppliers with CEP (COS) on PharmaCompass.

Cholesterol WC

A Cholesterol written confirmation (Cholesterol WC) is an official document issued by a regulatory agency to a Cholesterol manufacturer, verifying that the manufacturing facility of a Cholesterol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cholesterol APIs or Cholesterol finished pharmaceutical products to another nation, regulatory agencies frequently require a Cholesterol WC (written confirmation) as part of the regulatory process.

click here to find a list of Cholesterol suppliers with Written Confirmation (WC) on PharmaCompass.

Cholesterol NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cholesterol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cholesterol API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Cholesterol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cholesterol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cholesterol NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cholesterol suppliers with NDC on PharmaCompass.

Cholesterol GMP

Cholesterol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Cholesterol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Cholesterol GMP manufacturer or Cholesterol GMP API supplier for your needs.

Cholesterol CoA

A Cholesterol CoA (Certificate of Analysis) is a formal document that attests to Cholesterol's compliance with Cholesterol specifications and serves as a tool for batch-level quality control.

Cholesterol CoA mostly includes findings from lab analyses of a specific batch. For each Cholesterol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Cholesterol may be tested according to a variety of international standards, such as European Pharmacopoeia (Cholesterol EP), Cholesterol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cholesterol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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